Technical Briefing Seminar 20 October 2016 1 |
Medical Devices:
how interesting they are!
Josée Hansen
20 October 2016
Technical Briefing Seminar 20 October 2016 2 |
Outline
Commonalities and differences between medicines
and medical devices
Status of medical device regulations worldwide
Model Regulatory Framework for medical devices
What do you think are the major challenges in
regulating medical devices?
Technical Briefing Seminar 20 October 2016 4 |
Some questions
Thinking of medical devices…
How do I know they are safe?
Are they tested before being placed on the market?
Who can I ask when I have questions?
Does the doctor know how to use a device safely?
Adverse events: where to go?
Technical Briefing Seminar 20 October 2016 5 |
Medicinal product or medical device?
Condom
Pregnancy test
Artificial tears
Surgical gloves
Alcohol
A steriliser
Glucose 5%
Dialysis solution
Drug eluting stents
Microneedle patch with vaccine
Technical Briefing Seminar 20 October 2016 6 |
Definitions
medicinal product medical device
Any substance or mixture of substances that is manufactured for sale or distribution, sold, supplied, offered for sale of presented for use in: (i) the treatment, mitigation, cure , prevention or diagnosis of disease, an abnormal physical state or the symptoms thereof and abnormal physiological conditions in human or animal; or (ii) the restoration, correction or modification of organic functions in human or animal.
… instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: -diagnosis, prevention, monitoring, treatment or
alleviation of disease, -diagnosis, monitoring, treatment, alleviation of or
compensation for an injury, -investigation, replacement, modification, or support of the
anatomy or of a physiological process, -supporting or sustaining life, -control of conception, -disinfection of medical devices, -providing information by means of in vitro examination of
specimens derived from the human body;
-and does not achieve its primary intended action by
pharmacological, immunological or metabolic means.
Technical Briefing Seminar 20 October 2016 7 |
Commonalities and differences
Medicines Medical devices (+IVDs)
Diversity Approx. 40 NCE’s /year >>> 100,000; average
commercial life cycle 18 months
Innovation ‘Revolution’ Incremental improvement
Durability Single use Single use, multiple use,
permanent
Responsibilities Physician; pharmacist Usually not assigned
Context for use Independant Higly dependant
Clinical guidelines Detailed prescribed Not mentioned
Technical Briefing Seminar 20 October 2016 8 |
Commonalities and differences
Medicines Medical devices (+IVDs)
Benefit/risk assessment Each individual product Risk classes. Premarket
assessment of high risk medical
devices
Nomenclature International Non Proprietary
Name
GMDN
UMDNS
ISO 9999
UNSPSC
Others
Industry composition Dominated by large
multinationals; Small # of SMEs
Over 80% SMEs;
20 companies dominate sales
revenue
Sales global 900 billion US$ > 500 billion US$
Technical Briefing Seminar 20 October 2016 9 |
Regulation
Medicines Medical devices
Regulatory framework
All countries 58% of countries for MDs, Less for IVDs
Medicines Medical devices
US
1937 1976
EU 1965 1993
Beginning of Regulatory Controls
Technical Briefing Seminar 20 October 2016 10 |
medicines medical devices
Number of guidance
documents developed by WHO
• > 75 general QA standards,
good practices, guidelines
• 625 test specifications included
in the International
Pharmacopeia
• > 200 international chemical
reference standards
good review practices for
medicines and medical devices
blood products
< 10 guidelines IVDs as part of PQ
biotherapeutics including
vaccines
7 general documents for both
vaccines and biotherapeutics
8 general documents all vaccines
5 biotherapeutic specific
57 vaccine specific
Guidance by WHO
Technical Briefing Seminar 20 October 2016 11 |
Medicinal products Medical devices
efficacy safety and performance
interaction with the human body compatibility
placebo controlled and comparative studies clinical investigation
large numbers of patients included clinical evaluation
data not published
Clinical Trials
/blind.gif2http://www.thejabberwock.org/blog/ .html1_F2249/fig_tab/nm.11/n16http://www.nature.com/nm/journal/v
Performed by: Performed by:
Doctors Engineers incremental improvements
Technical Briefing Seminar 20 October 2016 12 |
Marketing Authorisation
Medicinal products Medical devices
one single system concept of risk class: essential requirements applicable to all risk classes
competent authority determines prescription status risk assessment by manufacturer
assessment of clinical trials bibliographic data
benefit / risk safe at the intended purpose; risk / benefit
Competent Authority, experts Conformity Assessment Bodies
national licenses for an established market Prioritization of products in an existing market
high threshold low threshold
Technical Briefing Seminar 20 October 2016 13 |
Medicinal products Medical devices
prescribing and dispensing strictly regulated prescribing and dispensing not regulated, linked to professional skills
responsibility assigned no single responsibility assigned
efficacy is not dependent on context: skills and physical environment
efficacy and effectiveness are context dependent
treatment guidelines available medical devices included in a treatment guideline to a limited extend
effectiveness studies performed limited benefit / cost data
comparative studies; systematic reviews very limited data publicly available
Use
Technical Briefing Seminar 20 October 2016 14 |
Medicinal products Medical devices
pharmacovigilance legislation: new and detailed PMS system in legislation
responsibility of Marketing Authorisation Holder responsibility of manufacturer
reporting system regulated and well established not properly implemented by manufacturers and monitored by authorities
effective? few data
Post Market Surveillance
Technical Briefing Seminar 20 October 2016 15 |
WHO Initiatives
Prequalification for IVDs – http://www.who.int/diagnostics_laboratory/evaluations/en/
Management in health care – http://www.who.int/medical_devices/management_use/en/
Regulation
Technical Briefing Seminar 20 October 2016 16 |
WHO Mandate
WHA 67.20 Regulatory System Strengthening for medical
products
– … to prioritize support for establishing and strengthening
regional and subregional networks of regulatory
authorities, as appropriate, including strengthening areas
of regulation of health products that are the least
developed, such as regulation of medical devices,
including diagnostics;
http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf
Global Survey on the Status of Medical Device Regulations | 29-30 September 2015 17 |
Regulatory status: global
Technical Briefing Seminar 20 October 2016 18 |
Regulatory status by region
N=194
15
23
10
48
5
12
19
6
10
3
3
12
13
6
1
2
3
3
AFRO
AMRO
EMRO
EURO
SEARO
WPRO
Number of countries
WH
O r
egio
ns
Regulatory Status of Medical Devices by Region
Countries withRegulations
Countries withoutRegulations
Data not available
Technical Briefing Seminar 20 October 2016 20 |
Model Regulatory Framework
A Model Regulatory Framework for medical
devices including IVD’s with global input and
reflecting a modular approach in regulating
medical devices – How to begin regulating?
– What to regulate: harmonized definitions and guiding
principles
– How to regulate: stepwise development and
implementation
– When to regulate: priorities and transitional period
Technical Briefing Seminar 20 October 2016 23 |
Target audience
Countries with no or limited regulatory framework in place
With the ambition to improve this situation
The legislative, executive and regulatory branches of
government
Technical Briefing Seminar 20 October 2016 24 |
Convergence and harmonization
Convergence and harmonization
– Definition of a medical device
– Classification of medical devices
– Essential principles of safety and performance
– QMS
– Standards
– …
Confidence building and Information sharing
Reliance and recognition
Technical Briefing Seminar 20 October 2016 25 |
Two steps approach
Basic level controls and enforcement
– Legal framework
– Market oversight
– Reporting system
Expanded level controls and enforcement
– regulatory controls depending on the priorities of the country
Technical Briefing Seminar 20 October 2016 27 |
Regulating medical devices - challenges
Less developed regulatory systems than for vaccines and
medicines, particularly in LIMC’s
Lack of awareness
Characteristics of medical devices as a product group
Regulating in an existing market
Lack of specialized knowledge and resources to draft and
implement medical devices regulations
Lack of resources
Technical Briefing Seminar 20 October 2016 28 |
Good regulatory practices
Critical elements for regulating medical devices
– Political commitment
– Legal framework
– Implementation plan
– Competent authority with enforcement power
– Involvement of stakeholders
– Transparent and impartial
Importance of convergence, harmonization, reliance and
recognition
Technical Briefing Seminar 20 October 2016 34 |
Questions?
In your opinion, what is the future of medical devices?
What can WHO do to take this further?
How can your organizations be involved?
How can the countries you represent benefit the most?
Technical Briefing Seminar 20 October 2016 36 |
Objective of the WHO Global Model
A Model Regulatory Framework for medical devices
including IVDs with global input and reflecting a modular
approach in regulating medical devices to be used by
national regulatory agencies in order to formulate laws and
regulations to define and control the national market in
medical devices in the interest of public health
Technical Briefing Seminar 20 October 2016 37 |
Working Group Members
Mr. Abdullah S. AL-Dobaib
• Executive Director of Registration and Licensing,
Saudi Food and Drug Authority
Tuncay Bayrak
• Assistant Health Expert, Republic of Turkey Ministry of
Health Michael Gropp
Alan Kent
• Consultant
Agnes Kijo
• Manager, Medical Devices and Diagnostics Registration,
Tanzania Food and Drugs Authority (TFDA)
Niall MacAleenan
• Medical Device Lead/Clinical Asessment and Policy
Manager, Health Products Regulatory Authority, Ireland
Nancy Shadeed
• Special Advisor, Health Canada
Maura Linda Sitanggang/ Lupi Trilaksono
• Director General of Pharmaceutical Services and
Medical Devices, National Agency of Drug and Food
Control, Indonesia
Shelley Tang
• Stellar Consulting
Kim Trautman
• Associate Director, US Food and Drug Administration
Woei Jiuang Wong
• Director, Health Sciences Authority, Medical Device Branch, Health Products
Regulation Group, Singapore
Technical Briefing Seminar 20 October 2016 40 |
Publications
http://new .paho.org/hq/dmdocuments/2009/AmodelRegulatoryProgramforMedicalDevices_AnInternal
Guide.pdf?ua=1
A Model Regulatory Program for Medical
Devices: An International Guide
2001 PAHO
http://apps.w ho.int/iris/bitstream/10665/42744/1/9241546182.pdf
Medical Device Regulations: Global
overview and guiding principles 2003 WHO
http://w w w.imdrf.org/docs/ghtf/f inal/steering-committee/technical-
docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf
The GHTF Regulatory Model 2011
http://w w w.ahwp.info/sites/default/f iles/ahw p-
f iles/8_Call_for_Comments/TCOB/AHWPTC_P01_2014.pdf
AHWP Playbook for implementation of
medical device regulatory
frameworks 2014
Technical Briefing Seminar 20 October 2016 42 |
The Model Regulatory Framework for medical
devices does not cover:
Establishing a single nomenclature system
Norms and standards for medical devices
Guidance on combination products
Financing of the regulatory system for medical devices
Technical Briefing Seminar 20 October 2016 43 |
Basic Elements
58%
51%
65%
52%
60%
41%
57%
60%
23%
Essential principles
Labelling
Registration of Devices
Registration of Establishment
Import controls
Market surveillance
Adverse event reporting
Enforcement
FSCA Monitoring
Pre-Requisites
Pre-Market
Post-Market
N=110
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